Extemporaneous medicines are dosage forms that are manufactured directly in a pharmacy in accordance with a prescription from a doctor and especially for a particular patient. In the article, such drugs are considered in more detail. Also in the article we will talk more fully about the fact that these are extemporaneous drugs.
Classification
The classification of extemporal drugs is as follows.
- Suppositories.
- Decoctions, infusions.
- Liniment, suspension, emulsion.
- Eye drops (if the pharmacy has an aseptic block).
- Injection solutions.
- Pastes, ointments.
- Dosage powders.
- Solutions, drops intended for external and internal use.
The organization of intra-pharmaceutical quality control of extemporaneous medicines must be strictly observed.
The history of such drugs, the prevalence in the world
Medicines, since the most ancient times, were made in pharmacies. The most extensive extemporal recipe was distributed in Europe in the Middle Ages, when healers independently studied the properties of products of animal origin, minerals, plants. The development of alchemy in Europe has caused an increase in the rate of accumulation of knowledge in mineralogy, botany, and chemistry. Many doctors studied alchemy and at the same time the properties of various products and substances that they used.
In the modern world, such a recipe is ambivalent. In some countries (for example, in Portugal, Israel), extemporaneous manufacture of drugs in pharmacies is prohibited, but in other countries (France, USA, Germany) this formulation is very common. In Russia, every year the number of pharmacists who fully possess the skills of pharmacy preparation of medicines is greatly reduced. Despite the fact that the state is trying to stimulate pharmacies (for example, in St. Petersburg pharmacies that manufacture extemporaneous drugs have a substantial discount on the rental of premises), extemporaneous formulations are very rare, since the cost of preparing the drugs is very large and the payback is extremely low. At the same time, in the USA, the preparation of drugs in pharmacies is widespread and well paid: the cost of preparing eye drops for one prescription often reaches 300 dollars or more.
Nevertheless, in some pharmacies the manufacture of extemporaneous medicines is also used at present, however, as before, it is not popular. This is due to the fact that the pharmaceutical industry offers a fairly extensive assortment of medicines intended for the treatment of a wide variety of diseases. As a rule, you can always pick up the finished medicine, rather than ordering it at the pharmacy.
So, now it’s clear that these are extemporaneous drugs.
Advantages of extemporaneous formulation
The main advantage of preparing medicines directly at the pharmacy is the ability to determine the optimal dosage for a particular patient, taking into account the characteristics of his body as a whole and the disease in particular. Treatment in this case becomes as safe and effective as possible. This becomes especially important if a person has contraindications to the use of ready-made medications (has pathologies of the heart or other organs, is prone to allergic reactions).
This is the main argument in favor of preparing drugs at the pharmacy, because not all drugs offered by the pharmaceutical industry are suitable for patients.
disadvantages
Among the shortcomings, difficulties in the quality control of dosage forms should be noted. In industrial conditions, you can take control samples from a large number of substances, analyze them, and then produce thousands of tablets. In this case, the cost of monitoring will be minimal, and the quality of dosage forms will certainly be higher.
The OKPD 2 code for extemporaneous drugs is 24.42.13.869.
Extemporal Recipe Technology
In order to manufacture drugs according to an extemporaneous formulation, pharmacy points use such facilities as:
- washing;
- autoclave;
- aseptic block (a box intended for the preparation of sterile dosage forms);
- cocktory (distillation);
- assistant.
The main room is the assistant, it is in it that the main technological process is carried out. Most often, in the center of such a room is a long table, headed by a technologist-pharmacist, advising assistants (pharmacists, pharmacists) on the technological issues of preparing dosage forms. In addition, the technologist issues potent, toxic substances, if necessary, for the manufacture of a medicine, to assistants in the safe for signing. Also, the technologist is responsible for filling the bar-glasses, filling out a journal with reports on filling the bar-glasses and prepared medicines.
As a rule, the assistant has up to 6 jobs. One of them is intended for the manufacture of medicines in liquid forms (solutions, potions), the second is used in the preparation and packaging of powder dosage forms, the third is for the manufacture of candles, ointments. In addition, some places are sometimes duplicated. In the central part of the table there are bar-eyes - special bottles with ground covers, in which powders, ointment bases, and other auxiliary and medicinal substances are stored. Bar-glasses are placed on turntables in accordance with the place to which they relate. For example, bar-eyes, in which ointment bases are stored, are located in close proximity to the workplace where soft dosage forms are prepared.
Workplace equipment
Each workplace is equipped with a fluorescent lamp, a water supply is connected to it, through which purified water is supplied from the distillation. They draw water into a special burette. Also at each workplace should be present: a dish cart with funnels, mortars, spatulas and other equipment, scale and hand scales. More complex dishes (for example, measuring cylinders) used to create drugs are located in the assistant's office in a separate glass cabinet.
In addition, the assistant has a table for the pharmacist-analyst, whose task is to analyze the prepared dosage forms by indicators such as quantitative and qualitative component, design, appearance. On the analyst’s table are: schemes of methods for the quantitative assessment of drugs and qualitative reactions, the current pharmacopeia, a set of bottles containing standard solutions for titrating a burette, a set of reagents, and a refractometer.
Thus, various decoctions, injection solutions, ointments can be made in a pharmacy. The drug is made in accordance with a prescription prescribed by a doctor, which takes into account all the features of the patient. At present, extemporaneous formulation requires that all rules and regulations are followed. This allows you to improve the quality of drugs manufactured in the pharmacy.
Who controls the quality of extemporaneous drugs?
Pharmacist-technologist
A pharmacist should always be present during the manufacturing process of drugs, as extemporal recipes often require regular oral questions, the purpose of which is to control the knowledge of assistants. For example, a technologist may name an assistant one ingredient of a drug, and the assistant, in turn, should name all the others.
Thus, the technologist controls the entire production process and is responsible for the activities of all pharmacy employees. The duties of the technologist also include regular quality control of manufactured medicines and all its components separately. The results of all inspections of the technologist should be recorded by him in special journals and reports.
Conclusion
Thus, the preparation of extemporaneous drugs is an extremely responsible process that is strictly controlled. Errors in this case are unacceptable, because an improperly prepared medicine can be harmful or even dangerous for the patient.
Unfortunately, extemporaneous formulations are currently in decline, despite its benefits and the desire of government authorities to stimulate the development of this pharmaceutical industry. However, some pharmacies still provide patients with the opportunity to receive medicines made according to individual prescriptions from a doctor.